Medtronic DDBC3D1 Patient Manual

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Implantable Cardioverter Defibrillator
Patient Manual
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
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Innovating for life.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries: CareLink, Medtronic, Medtronic CareAlert, Medtronic CareLink. All other trademarks are the property of their respective owners.
© Medtronic, Inc. 2012 M951966A001A 2012-07-09
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How to contact Medtronic

Contact us by phone

Our experienced Patient Services group is available to answer any questions or concerns you may have about your heart device. To speak directly with a Patient Services Specialist, call 1-800-551-5544. Our staff is available Monday through Friday from 8:00 AM to 5:00 PM (Central Standard Time).

Contact us online

Medtronic is dedicated to providing you with the most up-to-date information available about your Medtronic heart device. Website information is available 24 hours a day.
• Medtronic website: www.medtronic.com
• Patient Services website: www.medtronic.com/rhythms
If you would like to submit questions, suggestions, or requests to us online, you can use the online form provided at www.medtronic.com/corporate/contact.jsp.
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Contact us by mail or fax

Medtronic, Inc. Patient Services Department Mail Stop MVS 14 8200 Coral Sea Street NE Mounds View, MN 55112
Fax: 763-367-5809

Contacting Medtronic about your ID Card

To update information on your ID card or if you have questions about your ID card, see “Your heart device ID card” on page 89.
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Information about you and your device

Your personal information

Your name Your doctor’s name Specialty Your doctor’s name Doctor’s phone Your medications

Emergency contact information

Name/address/phone Name/address/phone

Your heart device information

Type of heart device Lead 1 model number Serial # Lead 2 model number Serial # Lead 3 model number Serial # Date of i mpl ant H osp ital whe re i mpla nte d
Specialty
Serial #
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Contents
How to contact Medtronic 3
Contact us by phone 3 Contact us online 3 Contact us by mail or fax 4 Contacting Medtronic about your ID Card 4
Chapter 1 Why read this manual? 13
Frequently asked questions 14
Chapter 2 Living life with your heart device 25
Food and medications 26 Recommendations about your physical activity 26
Recreation and activities 27 Driving a car 27
What you need to know about electromagnetic compatibility (EMC) 28
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General guidelines for avoiding interference from electrical items or magnets 32
Examples of items that have low or no risk of interfering with your device 42
Precautions about medical procedures 44
Medical procedures that are not recommended 45 Medical procedures that require some precautions 46 Acceptable medical procedures 48
Chapter 3 Your heart has a natural rhythm 51
The anatomy of the heart 51 Electrical conduction in the heart 55 How abnormal heart rhythms affect the heart 58
Tachyarrhythmia – When the heart beats too fast 59 Bradycardia – When the heart beats too slowly 62
Chapter 4 About your heart device 65
What is an ICD? 66
Your heart device 66 Leads 67
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What does my heart device do? 70 What types of therapies does my heart device provide? 70
Therapies for a fast or uneven heart rhythm 71
Therapy for a slow heart rhythm 73 What do the therapies feel like? 74 What is Medtronic CareAlert monitoring? 75
Conditions that Medtronic CareAlert monitoring can
detect 76
Checking your Medtronic CareAlert status 77
Chapter 5 Your implant procedure and recovery 79
The implant procedure 80
Making the incision and inserting the leads 80
Testing the leads 81
Implanting the heart device and closing the incision 81 Potential risks after the implant procedure 82 Recovering after your implant surgery 83 Follow-up appointments 85
Chapter 6 Registering your heart device 87
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Heart device registration form 88 Your heart device ID card 89
Carry your heart device ID card with you at all times 89 To request a new heart device ID card or update your
personal information 90 If you change your doctor 90
Medtronic heart device travel card 90
Chapter 7 Follow-up care 93
Follow-up information 94
Remote monitoring with the Medtronic CareLink Service 95
Medtronic CareLink Programmer 98
Reviewing information saved by your heart device 99 When to call your doctor or nurse 100 Heart device replacement 101
Chapter 8 Caring for yourself 103
Dealing with anxiety and getting the support you need 104 Medical care 107
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Planning for an emergency 108 What your family and friends should know 109
Medtronic Warranty 111
Glossary 113
Index 127
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Why read this manual?

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Your doctor or doctors should be your first source of information about your heart condition and your general health.
If you have questions about your heart device that are not covered in this manual, contact Medtronic Patient Services (see “How to contact Medtronic” on page 3).
To view or download English and Spanish patient manuals, see www.medtronic.com or contact Medtronic Patient Services.
This manual is for people who are about to have or already have an implantable cardioverter defibrillator (ICD). This manual explains what the heart device is, how it is implanted, what it feels like when you receive therapy from the heart device, and what you can expect after you have your heart device. It’s a good idea to encourage your family and caregivers to review this manual. For your convenience, words that appear in bold are defined in the glossary starting on page 113.
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Frequently asked questions

New patients often have the same initial concerns about their heart devices. Here are some of the questions new patients frequently ask.
Why do I need this heart device?
An ICD is designed to relieve heart disease symptoms for most patients. Although this heart device does not prevent or cure your underlying heart rhythm condition, it should improve your quality of life and help you get back to doing things that you haven’t been able to do for a while.
Heart medications and surgical procedures may be prescribed instead of, or in addition to, an ICD. Based on your individual health condition, your doctor has determined that the treatment provided by a heart device may help to improve your symptoms.
Although your heart device is not a cure, it does help to protect you from heart rhythms that can weaken or even endanger your health. Many patients say that this heart device gives them and their families a sense of security. See “Caring for yourself” on page 103 for guidance on dealing with anxiety and other concerns.
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Will I be able to drive?
Whether you will be able to drive or not depends on your individual heart condition. The concern about driving is that you might faint if your heart starts to beat dangerously fast. Many people with a heart device are able to resume driving if their doctor approves and if allowed by the laws and insurance regulations in their state. For more information, see “Driving a car” on page 27. If you have concerns, talk with your doctor.
Will I be able to travel?
Most people who have a heart device can travel without taking special precautions if they follow their doctor’s instructions.
Wherever you travel, your heart device will monitor your heart and provide therapy whenever it is needed. You can travel knowing that resources for your device are available in 120 countries (see the back cover of this manual for information on contacting Medtronic headquarters located worldwide). When you travel, your doctor may also be able to check your heart device remotely with the Medtronic CareLink Service (see page 98 for more information).
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It is unlikely that your heart device will trigger the security gates at airports or other secure buildings. If it does, present your heart device ID card. If a handheld screening wand is used, ask the security operator not to hold it over your heart device and not to wave the wand back and forth over your heart device. See “Security systems” on page 41 for more information.
A multilanguage heart device travel card is available that provides instructions in several languages for safe security scanning; the card is especially useful for international travel. See page 90 for more information about the multilanguage heart device travel card.
If you have any other travel-related questions, contact Medtronic Patient Services (see page 3) or consult the Medtronic travel website at www.medtronic.com/traveling.
Can I walk through antitheft systems found in public places?
Yes, simply walk through the antitheft system at a normal pace. Under some circumstances, the systems located in stores, libraries, and other places may temporarily interfere with your heart device if you stop or
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linger near this equipment. The interference stops when you move away from the equipment.
Can I use a mobile phone?
Yes, you can use mobile phones (including cellular phones and other wireless phones). However, mobile phones may cause electrical interference with your heart device when the phone is turned on and held too close to your heart device. Any effect is temporary, and simply moving the phone away will return the heart device to its previous state of operation.
To avoid any possible interference between mobile phones and your heart device, keep all mobile phones at least 6 inches (15 centimeters) away from your heart device. When using a mobile phone, hold it to the ear that is farthest away from your heart device. Also, do not carry a mobile phone close to your heart device, such as in a shirt pocket (or in a pants pocket if your heart device is implanted in your abdomen). For more information about using mobile phones and other wireless communication devices, see page 32.
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Can I use a microwave oven and other electrical items?
Yes, you can use a microwave oven as well as major appliances, electric blankets, and heating pads. See “Living life with your heart device” on page 25 for information about electrical items and any restrictions or cautions you should know about.
Will my heart device need to be replaced?
Yes. Because your heart device operates using a battery sealed inside the heart device, the entire heart device will need to be replaced when battery power falls to a low level. Battery power is affected by many factors, including how often your heart device provides therapy to your heart. The battery for your type of heart device typically lasts 4 to 7 years after it is implanted.
The battery power is checked at each heart device follow-up appointment. Your doctor or nurse will let you know when you need to have your heart device replaced.
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How often will my doctor need to check my heart device?
When you go home after your implant surgery, your doctor will periodically check your heart device. These follow-up appointments can be performed at your clinic, or if your clinic subscribes to the Medtronic CareLink Service, you can send your heart device information directly to your doctor or clinic from home. For more information about follow-up services, see “Follow-up care” on page 93.
How do I know if my heart device battery is still working?
The strength of your heart device battery is checked during your follow-up appointments, either in the clinic or through built-in device monitoring. Medtronic CareAlert monitoring is a safety feature built into your heart device that can be set up by your doctor to alert you with a beeping sound when the heart device battery power is getting low. For more information about the Medtronic CareAlert monitoring feature, see “What is Medtronic CareAlert monitoring?” on page 75. Because the battery is sealed inside your heart device and cannot be recharged, your heart device will need to be replaced when the battery power is low. For
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more information about heart device replacement, see “What is Medtronic CareAlert monitoring?” on page 75.
What if my heart device is making a beeping sound?
Your heart device may make a beeping sound if the Medtronic CareAlert monitoring feature is turned on. Your doctor can have your heart device alert you with a beeping sound under certain conditions, such as the following conditions:
• The number of therapies you have received has increased.
• The battery power of your heart device is low.
If one of these conditions is detected by your heart device, it will make a beeping sound for up to 30 seconds, at least once a day. The alerts will continue until your heart device is checked by your doctor or nurse. Do not be alarmed by the beeping. This alert feature is designed to get your attention. If you hear beeping tones from your heart device, call your doctor for instructions. For more information about the Medtronic CareAlert monitoring feature, see “What is Medtronic CareAlert monitoring?” on page 75.
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Will my device deliver a therapy shock during normal activity?
This can happen, but it is unlikely. Your heart device is designed to respond to abnormal heart rates and rhythm patterns. Normal exercise or physical activity shouldn’t trigger your heart device to deliver a therapy shock.
If this ever happens, stop the activity and notify your doctor. Your doctor may change the settings of your heart device to prevent this from happening.
Can others feel a therapy shock if they are touching me?
Though it is very unlikely, if you receive a therapy shock, anyone touching you may feel the shock as a muscle spasm or tingle. This can be startling, but it will not hurt the person.
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What if I receive a therapy shock?
Ask your doctor or nurse what you should do if your heart device delivers a therapy shock. Your doctor or nurse should provide you with specific instructions about when you should contact your doctor if you have received a therapy shock.
In general, follow these steps if you feel the symptoms of a rapid heart rhythm or if you receive a therapy shock:
1. Stay calm and move to where you can lie down or sit comfortably.
2. Have someone stay with you until you feel better. If you receive more than one therapy shock or if you remain
unconscious for more than 1 minute, have a companion call 911 for an ambulance.
If you remain unconscious and you have no pulse, a companion trained in cardiopulmonary resuscitation (CPR) should begin CPR immediately. When your heart starts beating again, your companion should stop CPR.
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Note: Anyone touching you during a therapy shock might feel your muscles contract slightly; they also might see you jump with a sudden start. A therapy shock will not harm a person touching you.
3. If you do not feel well after the shock, have someone call your doctor and take you to the hospital emergency room.
4. Follow your doctor’s or nurse’s directions about when to call your doctor after receiving a shock. You may be asked the following questions:
– What were you doing right before the shock?
– What symptoms did you notice before the shock?
– How did you feel right after the shock?
– How are you feeling right now?
Can I have sexual relations?
People often have questions about resuming sexual relations after receiving a heart device. Most people resume sexual activity, based on their doctor’s guidance. You and your partner should be able to enjoy all the benefits of intimacy.
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Any kind of physical activity is not likely to cause your heart device to deliver a shock. But if it does happen during intercourse, stop and notify your doctor just as you would if it happened during exercise. Your partner will not be hurt by the shock. They may feel a tingle or slight muscle spasm, but nothing more.
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Living life with your heart device

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Many people resume their normal daily activities after full recovery from surgery (see “Your implant procedure and recovery” on page 79). However, there may be certain situations that your doctor will ask you to avoid. Your doctor will provide the most important guidance for your particular condition.
This chapter has important information about the following topics:
• Food and medications (see page 26).
• Your physical activity now that you have a heart device (see page 26).
• Information and instructions about any electrical equipment that may cause interference with your heart device (see page 28).
• Precautions about certain types of medical procedures (see page 44).
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Food and medications

Your doctor may instruct you to eat or avoid eating certain foods. For information about food, talk with your doctor.
Your doctor may prescribe medications that will treat your heart condition. Please talk with your doctor about medications.

Recommendations about your physical activity

Upon the advice of your doctor, you can gradually return to your normal lifestyle and to activities such as these:
• Pursuing hobbies or recreational activities
• Returning to your job
• Resuming strenuous activity
• Resuming sexual activity
•Traveling
Your doctor might ask you to avoid situations where a few seconds of unconsciousness could be dangerous to you or others. Such situations might include driving, swimming or boating alone, or climbing a ladder.
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Recreation and activities

Avoid rough physical contact that could cause you to fall or to hit your implant site. Your heart device can be damaged or your leads could become detached from the heart device during rough contact.
• If you use a rifle or shotgun, rest the butt on the shoulder of the side opposite from your heart device.
• In activities that use a shoulder harness, protect your heart device and leads from jolts or rough rubbing.
• If you plan to scuba dive, discuss your medical condition with your doctor. General recommendations about scuba diving vary depending on many factors. Ask your doctor to contact Medtronic Technical Services for the most up-to-date information about scuba diving recommendations.
If you have additional questions about any recreational activities you normally pursue, contact Medtronic Patient Services (see page 3).

Driving a car

Discuss with your doctor whether you can safely drive a car or other vehicle. You may be able to resume driving, depending on local laws
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and insurance regulations and on your medical condition. Your doctor will decide what is best for your safety and the safety of others.
Seat belts are a very important safety device and should always be worn while driving or riding in a vehicle. While you are driving or riding in a vehicle, the shoulder seat belt strap may feel uncomfortable during the first few weeks after surgery. You can place a soft towel between the seat belt strap and your implant site to cushion the area.

What you need to know about electromagnetic compatibility (EMC)

Everything that uses electricity produces an electromagnetic energy field. This energy field surrounds the electrical item while it is
connected to a source of electricity (even a battery source). The energy field is strongest near the item and weakens with distance from the item.
The relationship between these energy fields and your heart device is called electromagnetic compatibility (EMC). Most electromagnetic energy fields are small and weak and do not affect your heart device. Electrical items that generate strong electromagnetic energy fields may not be compatible with your heart device.
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Because your heart device is designed to sense the electrical activity of your heart, it is possible that it may sense a strong electromagnetic energy field outside your body and deliver a therapy that is not needed or withhold a therapy that is needed.
Several safeguards are built into your heart device to shield it from strong electromagnetic energy fields. For example, the metal case of your heart device acts as a shield against electromagnetic energy fields. There are also electronic filters built into your heart device that help your heart device distinguish between external electromagnetic energy fields and the internal electrical pulses of your natural heartbeat.
You can avoid potential EMC problems by keeping your heart device a minimum distance away from the electrical item. See the following pages for more information, including the recommended safe distances for certain types of electrical items.
How could electromagnetic energy fields affect my heart device?
High electromagnetic energy fields could affect how your heart device senses your heart rhythm. Because your heart device is designed to
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sense the electrical activity of your heart, it may also sense a strong electromagnetic energy field outside your body.
If your heart device is exposed to a strong electromagnetic energy field, it may not detect an abnormal heart rhythm or it may deliver a therapy shock when your heart does not need it. Any effects of electromagnetic energy fields on your heart device are temporary and will stop when you move away from the source of the electromagnetic energy field.
What do I do if I think that an electrical item is affecting my heart device?
If you feel dizzy, feel rapid or irregular heartbeats, or receive a shock while using an electrical item, release whatever you are touching or move away from the item. Your heart device should immediately return to its normal operation. If you receive a therapy shock or if your symptoms do not improve when you move away from the item, consult with your doctor or contact Medtronic Patient Services (see page 3).
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What about static electricity or shocks from household outlets?
Static electricity shocks will not damage your heart device. A “momentary” shock from an electrical outlet (110/220 volts) is unlikely to damage your heart device, depending on how long you stay in contact with the outlet.
What items are safe and what kind of precautions do I need to take?
Most electrical items are safe for you to use. However, you should keep some items that produce a stronger electrical field a minimum distance away from your heart device. This minimum distance can range from 6 to 12 inches (15 to 30 centimeters) or more, depending on the type of item. Refer to the information beginning on page 32 for recommended safe distances. Also, before entering an area where signs are posted prohibiting persons with an implanted heart device such as a pacemaker or defibrillator, consult with your doctor.
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General guidelines for avoiding interference from electrical items or magnets

The following pages provide tips on how to avoid any possible temporary effects of electromagnetic energy fields on your heart device. If you have questions about electromagnetic energy fields or the safe use of a specific item that is not listed in this chapter, contact Medtronic Patient Services (see page 3).
Proper grounding of electrical items
To avoid interference from electrical current that may leak from improperly grounded electrical items and pass through your body, observe the following precautions:
• Make sure that all electrical items are properly wired and grounded.
• Make sure that electrical supply lines for swimming pools and hot tubs are properly installed and grounded according to local and national electrical code requirements.
Wireless communication devices
Wireless communication devices include transmitters that can affect heart devices. When using wireless communication devices, keep them
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at least 6 inches (15 centimeters) away from your heart device. The following items are examples of such devices:
• Handheld cellular, mobile, or cordless telephones (wireless phones); two-way pagers; personal digital assistants (PDAs); smartphones; and mobile email devices.
• Wireless-enabled devices such as laptop, notebook, or tablet computers; network routers; MP3 players; eReaders; gaming consoles; televisions; DVD players; and headsets
• Remote keyless entry and remote car starter devices
What else do I need to know about using a wireless device?
Heart devices have been tested with many types of wireless device technologies. To ensure your heart device operates correctly when you are using a wireless device that is turned on, you can keep your heart device at least 6 inches (15 centimeters) away from the antenna of the device, such as a telephone, by holding the telephone to the ear farthest away from your heart device. Do not carry the telephone in a pocket over the device or in a shoulder bag near the device.
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Household and hobby items
Caution: Household and hobby items that have motors or magnets or that generate electromagnetic energy fields could interfere with your heart device. You should move away from the interference source or turn off the source if you experience any dizziness or heart palpitations.
Keep your heart device at least 6 inches (15 centimeters) away from the following household and hobby items:
• Handheld kitchen appliances, such as electric mixers
• Sewing machines and sergers
• Personal care items, such as corded handheld hair dryers, corded electric shavers, electric or ultrasonic toothbrushes (base charger), or back massagers
• Items that contain magnets, such as bingo wands, mechanic's extractor wands (which use magnets to pick up metal items), magnetic bracelets, magnetic clasps, magnetic chair pads, or stereo speakers (even if the power for the speakers is disconnected)
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• Radio-controlled toys (antenna)
• Two-way walkie-talkies (less than 3 watts)
To avoid interference with your heart device, the following household and hobby items require special precautions:
Magnetic mattress pads or pillows – Items containing magnets can interfere with the normal operation of your heart device if they are within 6 inches (15 centimeters) of the device. Avoid using magnetic mattress pads or pillows because they cannot easily be kept away from the device.
Induction cook tops – An induction cook top uses an alternating magnetic field to generate heat. You should keep your heart device at least 24 inches (60 centimeters) away from the heating zone when the induction cook top is turned on. Most glass-topped or ceramic-topped ranges use conventional heating elements beneath their flat cooking surfaces. If you can use aluminum or glass cookware on your range and the cooking area stays hot after the burner has been turned off, your stove has conventional heating elements. This type of cook top will not affect your heart device. If you need the latest information about kitchen appliances, contact Medtronic Patient Services (see page 3).
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Electronic body fat scale – Using this type of scale is not recommended for heart device patients because it passes electricity through the body and can interfere with the device.
UPS (uninterruptable power source) up to 200 amperes – Keep your heart device at least 12 inches (30 centimeters) away from a UPS. If the UPS is operating by battery source, keep your heart device at least 18 inches (45 centimeters) away.
Electronic pet fences or invisible fences – Keep your heart device at least 12 inches (30 centimeters) away from the buried wire and the indoor antenna of electronic pet fences or invisible fences.
Home-use electric kilns – Keep your heart device at least 24 inches (60 centimeters) away from home-use electric kilns.
“Beach comber” metal detectors – Keep your heart device at least 24 inches (60 centimeters) away from the detector end.
Boat motors – Keep your heart device at least 12 inches (30 centimeters) away from electric trolling motors or gasoline-powered boat motors.
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Portable electric generators up to 20 kilowatts – Keep your heart device at least 12 inches (30 centimeters) away from portable electric generators.
Home power tools
Most home power tools should not affect heart devices; however, some home power tools could affect heart device operation. Consider the following guidelines to reduce the possibility of interference.
• To avoid electrical shock, keep all equipment in good working order.
• Be certain that plug-in tools are properly grounded or double insulated. Using a ground fault interrupter (GFI) outlet is a common safety measure.
Gasoline-powered tools and gasoline-powered yard equipment –
Keep your heart device at least 12 inches (30 centimeters) away from ignition system components in tools and equipment such as lawn mowers, tractors, snowblowers, leaf blowers, chain saws, and weed eaters. Turn off the motor before making adjustments.
Electric yard and handheld power tools (plug-in and cordless) – Keep your heart device at least 6 inches (15 centimeters) away from these tools.
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Car engine repair – Turn off car engines before making any adjustments. When the engine is running, keep your heart device at least 12 inches (30 centimeters) away from components of the ignition system.
Soldering guns and demagnetizers – Keep your heart device at least 12 inches (30 centimeters) away from these tools.
Industrial equipment
After recovering from implant surgery, you likely will be able to return to work, school, or daily routine. However, if you use or work near high-voltage equipment, sources of high electrical current, magnetic fields, or other electromagnetic sources that may affect device operation, consult with your doctor or contact Medtronic Patient Services (see page 3). You may need to avoid using, or working near, the following types of industrial equipment:
• Electric furnaces used in the manufacturing of steel
• Induction heating equipment and induction furnaces, such as kilns
• Industrial magnets or large magnets, such as those used in surface grinding and electromagnetic cranes
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• Dielectric heaters used in industry to heat plastic and dry glue in furniture manufacturing
• Electric arc and resistance welding equipment. Avoid welding with currents above 130 amps because it may temporarily affect the normal function of your heart device. If you need to use a welder with currents under 130 amps, first consult with your heart doctor. Your doctor can advise you on risks that device interference may pose for your medical condition. Contact Medtronic Patient Services (see page 3) for precautions you should take when using welding equipment, such as maintaining a 2-foot (60 centimeter) distance between the welding arc and your heart device, and placing the welding unit at least 5 feet from the work area. Note that aprons or vests will not effectively shield your heart device from the electromagnetic energy generated by welding equipment.
• Broadcasting antennas of AM, FM, shortwave radio, and TV stations
• Microwave transmitters. Note that microwave ovens are unlikely to affect heart devices.
• Power plants, large generators, and transmission lines. Note that lower voltage distribution lines for homes and businesses are unlikely to affect heart devices.
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Radio transmitters
Determining a safe distance between the antenna of a radio transmitter and a heart device depends on many factors such as transmitter power, frequency, and the antenna type. If the transmitter power is high or if the antenna cannot be directed away from your heart device, you may need to stay farther away from the antenna. Refer to the following guidelines for different types of radio transmitters:
Two-way radio transmitter (less than 3 watts) – Keep your heart device at least 6 inches (15 centimeters) away from the antenna.
Portable radio transmitter (3 to 15 watts) – Keep your heart device at least 12 inches (30 centimeters) away from the antenna.
Commercial and government vehicle-mounted radio transmitters (15 to 30 watts) – Keep your heart device at least 24 inches
(60 centimeters) away from the antenna.
Other radio transmitter (125 to 250 watts) – Keep your heart device at least 9 feet (2.75 meters) away from the antenna.
Transmission power levels higher than 250 watts – For more information, contact Medtronic Patient Services (see page 3).
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Security systems
Home security systems – It is unlikely that your device will be affected by home security systems.
Electronic antitheft systems, such as in a store or library, and point-of­entry control systems, such as gates or readers that include radio frequency identification equipment – These systems should not affect
your heart device, but as a precaution, do not linger near or lean against such systems. Simply walk through these systems at a normal pace. If you are near an electronic antitheft or entry control system and experience symptoms, promptly move away from the equipment. After you move away from the equipment, the heart device resumes its previous state of operation.
Airport, courthouse, and jail security systems – Given the short duration of security screening, it is unlikely that metal detectors (walk-through archways and hand-held wands) and full body imaging scanners (also called millimeter wave scanners and three-dimensional imaging scanners) in airports, courthouses, and jails will affect your heart device. When encountering these security systems, follow these guidelines:
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• Always carry your heart device ID card. This card is helpful if your heart device sets off a metal detector or security system.
• Minimize the risk of temporary interference with your heart device while going through the security screening process by not touching metal surfaces around any screening equipment.
• Do not stop or linger in a walk-through archway; simply walk through the archway at a normal pace.
• If a hand-held wand is used, ask the security operator not to hold it over or wave it back and forth over your heart device.
• If you have concerns about security screening methods, show your heart device ID card to the security operator, request alternative screening, and then follow the security operator’s instructions.

Examples of items that have low or no risk of interfering with your device

Patients frequently have questions about the items in the following list, which have low or no risk of temporarily interfering with your heart device. If you have questions about items not listed in this manual, contact Medtronic Patient Services (see page 3).
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Kitchen items – Microwave oven; electric, gas, or convection oven; toaster; blender; electric can opener; food processor; cordless electric knife.
Personal care items – Salon hair dryer; cordless shaver; electric blanket; heating pad.
Communication devices – Corded home or public telephone.
Home office items – Desktop or laptop computer; home-use copier,
printer, fax and scanner.
Home electronics items – AM and FM radio; cassette tape recorder; CD player; camcorder; video recorder (VCR); MP3 player; television; video game system; stereo; DVD player; remote control for entertainment system.
Miscellaneous items – Laundry and cleaning items, such as clothes iron, vacuum cleaner, and electric broom; pager that only receives messages; remote control for garage door; portable space heater.
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Precautions about medical procedures

Caution: Before you undergo any medical procedure, tell the health care professional, such as the doctor or nurse, that you have an implanted heart device.
• The health care professional may need to speak with your heart doctor before performing the procedure. Showing them your heart device ID card may be helpful.
• Some procedures may potentially affect the function of your heart device, and such procedures may require precautionary measures to prevent or minimize impact on your heart device.
Talk with your health care professional to weigh any potential risk against the benefits of the medical procedure. See the following pages for more information. Refer to the Glossary for definitions of medical procedures and other terms that appear in bold.
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Medical procedures that are not recommended

Some medical procedures should not be performed on anyone with a heart device. Talk to your health care professionals about finding alternatives to these procedures. Your doctor may decide to contact your heart doctor or Medtronic Technical Services for more information.
Table 1 lists procedures that are not recommended for someone with your heart device.
Table 1: Medical procedures that are not recommended
Warning: People with metal implants such as an implanted heart device and accompanying leads should not receive the following medical procedures:
Diathermy treatment (high frequency, short wave, or microwave)
This treatment can result in serious injury and damage to your heart device.
MRI (magnetic resonance imaging) scan This procedure can result in serious injury and damage to your heart device. If you are in a room where an MRI scanner is kept, the function of your heart device can be affected.
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Medical procedures that require some precautions

If health care professionals take certain precautions to avoid serious injury, damage to your heart device, and device malfunction, the medical procedures listed in Table 2 can be safely performed.
If you or your doctor have any concerns about the precautions that should be taken, your doctor should contact a Medtronic representative or Medtronic Technical Services.
The doctor should make sure that your heart device is operating correctly after completing the procedure.
Table 2 lists procedures that require some precautions.
Table 2: Medical procedures that require some precautions
Ablation (specifically, microwave ablation and radiofrequency ablation)
This treatment can result in serious injury, damage to your heart device, or device malfunction.
Computerized axial tomography (CT or CAT) scan This procedure can affect the function of your heart device.
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Table 2: Medical procedures that require some precautions (continued)
Electrolysis
This procedure can affect the function of your heart device.
Electrosurgery
This procedure and other procedures that use an electric probe to control bleeding, cut tissue, or remove tissue can result in serious injury, damage to your heart device, or device malfunction.
External defibrillation and elective cardioversion These procedures can affect the function of your heart device.
Hyperbaric Oxygen Therapy (HBOT) This procedure can damage your heart device and leads.
Lithotripsy This procedure can damage your heart device.
Radiotherapy (including high-energy radiation therapy) This procedure can damage your heart device and lead, or affect the function of your heart device.
Stereotaxis
This procedure can affect the function of your heart device.
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Table 2: Medical procedures that require some precautions (continued)
Therapeutic ultrasound
This procedure can result in permanent damage to your heart device.
Transcutaneous Electrical Nerve Stimulation (TENS), including neuro muscular electrical stimulation (NMES) A TENS device is not recommended for in-home use because it can affect the function of your heart device. If use of a TENS device is determined to be medically necessary, your doctor should contact a Medtronic representative for more information.
Transmitting loop for digital hearing aid
Using a transmitting loop can affect the function of your heart device.
Transurethral needle ablation (Medtronic TUNA This treatment can affect the function of your heart device.
®
therapy)

Acceptable medical procedures

Many medical procedures will not affect your heart device. However, the equipment used for the procedure must be used correctly and must be properly maintained.
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Tell your doctors and dentist you have an implanted heart device before beginning any medical or dental procedure.
Table 3 lists some of the acceptable medical procedures.
Table 3: Examples of acceptable medical procedures
Capsule endoscopy and pH capsule procedures are acceptable.
Dental procedures that use dental drills or ultrasonic probes to clean teeth are
acceptable. Dental x-rays are also acceptable.
Diagnostic radiology, such as x-rays and mammograms, are acceptable. For precautions on CT scans, see Table 2 on page 46.
Diagnostic ultrasound, such as echocardiogram, are acceptable.
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Your heart has a natural rhythm

3
To help you understand how your heart device works, it is helpful to understand how the heart functions and how abnormal heart rhythms can affect the heart. This chapter describes the anatomy of the heart and some of the most common types of abnormal heart rhythm conditions.
For details about your health and individual heart condition, always talk to your doctor.

The anatomy of the heart

The heart is a fist-sized organ that acts as a pump to circulate blood through the body. Arteries are the blood vessels that carry blood with oxygen and nutrients to all parts of the body. Veins are the blood vessels that carry blood depleted of oxygen and nutrients back to the heart and lungs.
The heart is actually a large hollow muscle divided into four chambers. The two upper chambers are referred to as the right atrium and the left
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atrium. The term atria, the plural of atrium, refers to both the right and the left atrium.
The lower chambers of the heart are called the ventricles and are referred to as the right ventricle and the left ventricle. The muscled wall dividing the right and left sides of your heart is called the septum.
The right atrium draws blood in from your body and pumps it into the right ventricle. The right ventricle then pumps the blood into the lungs to be reoxygenated. The left atrium draws oxygen-rich blood in from the lungs and pumps it into the left ventricle. The left ventricle then pumps the blood out to the rest of your body.
Each chamber of the heart contracts by squeezing its muscles together. Each contraction pushes blood from one chamber to the next chamber or out into the body. Heart valves regulate the flow of blood between each chamber and keep the blood flowing in only one direction. It is the actual opening and closing of the valves that creates what we hear as our heartbeat.
After each chamber contracts completely, pushing out most of the blood, it relaxes and fills with more blood again. In a healthy heart, each
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chamber contracts in a coordinated effort with the other chambers of the heart.
The atria contract first, filling the ventricles with blood. When the ventricles are filled, they both contract at the same time, moving the blood into the lungs and the rest of the body, as illustrated in Figure 1 on page 54.
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Right atrium
Right ventricle
Left atrium
Left ventricle
Septum
Figure 1: Four chambers of the heart contracting in a controlled
sequence to circulate blood throughout the body
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Electrical conduction in the heart

The muscle cells of the heart, just like all the muscle cells throughout your body, contract and relax in response to electrical impulses.
The electrical impulses that cause your heart muscle to contract are generated by the heart’s natural pacemaker, called the sinoatrial node (or SA node). The SA node is located on the upper inside wall of the right atrium. These natural electrical impulses move through the muscle of your heart in tiny thread-like paths, from the top of the atria to the bottom of the ventricles, then up the ventricles’ outer walls.
After the SA node releases an electrical impulse, the impulse travels across the top of the right atrium and the left atrium. The impulse then travels down through both atria. As the atria are stimulated, they contract from the top down, pushing blood into the ventricles. When the electrical impulse reaches the lower wall of the atria, the atrioventricular node (or AV node) is stimulated. The AV node delays the impulses just long enough for the atria to finish pushing blood into the ventricles, then it passes the impulse along organized pathways into the ventricles.
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Sinoatrial (SA) node
Atrioventricular (AV)
node
Figure 2: The electrical impulses that cause the heart to contract start
at the SA node and move through the atria to the AV node. The AV node controls when the impulse is released to travel through the ventricles.
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The AV node controls how quickly the impulse travels through the rest of the heart. This controlled impulse release helps coordinate when each chamber contracts. Without this control, the heart would not pump blood very productively. The coordination between the contracting chambers of the heart is very important for maintaining adequate blood flow between your heart and the rest of your body.
The electrical impulse passes down to the bottom of the ventricles. From here the pulse sweeps across the surface of the right and left ventricles from the bottom up, causing the ventricles to contract in the same bottom-up direction. This action pushes the blood out of the valves at the top of the ventricles to the lungs (from the right ventricle) and to the rest of the body (from the left ventricle).

The heart is very sensitive to the body’s needs

The rate at which the chambers of the heart contract is controlled by your brain and your autonomic nervous system.
If, for example, you start to jog instead of walk, your body’s demand for blood increases. Your heart automatically contracts faster when you are active in order to increase the amount of blood supplied to your body.
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How abnormal heart rhythms affect the heart

There are many reasons why a heart might not beat “normally.” Whether due to disease, defect, or injury, the heart’s conduction system can become unreliable. The areas of the heart that control the heart rhythm can malfunction, causing slow, fast, erratic, or uncoordinated heart rhythms. Any of these abnormal heart rhythms can affect the amount of blood supplied to the body.
The effects of abnormal heart rhythms can range from severe fatigue to sudden cardiac arrest (SCA).
If the heart is not beating normally because of a problem with its conduction system, then the problem may be one of two common abnormal heart rhythm conditions.
Here are the two common heart rhythm conditions:
Tac hy ar rh yth mi a – when the heart beats too fast
Bradycardia – when the heart beats too slowly
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These conditions can be treated with medications or by implanting a heart device. Sometimes they are treated with both methods. Your heart device is capable of treating the following heart conditions:
Tac hy ar rh yth mi a
Bradycardia

Tachyarrhythmia – When the heart beats too fast

A heart rate that is faster than what the body needs is called a tachyarrhythmia. A normal heart at rest beats between 60 and 100 beats per minute. Exercise or stress can cause the heart to beat faster, but this is a normal response to the body’s need for more blood. During a tachyarrhythmia, the heart beats at more than 100 beats per minute and can beat as fast as 400 beats per minute, making it an ineffective pump.
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Normal heart rate
72 beats per minute (bpm)
Tachyarrhythmia heart rate
144 beats per minute (bpm)
Figure 3: A normal heart rate compared to a tachyarrhythmia rate
Types of tachyarrhythmias
Tachyarrhythmias occur when overly sensitive cells in the heart release electrical impulses faster than the normal heart rate. Sometimes just a few cells of the heart are responsible for starting an abnormally fast heart rhythm. Tachyarrhythmias can start in either the upper heart chambers (atria) or lower heart chambers (ventricles).
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Atrial tachyarrhythmias
Atrial tachyarrhythmias start in the atria and are called atrial flutter or atrial fibrillation (AF). Your heart device may treat atrial
tachyarrhythmias. Ask your doctor if your heart device treats atrial tachyarrhythmias.
Ventricular tachyarrhythmias
Ventricular tachyarrhythmias start in the ventricles and are called ventricular tachycardia (VT) and ventricular fibrillation (VF). Because the ventricles pump blood to the body, both of these conditions can lead to a quick depletion of oxygen-rich blood to the body, a life-threatening condition.
• Ventricular tachycardia (VT) is a heart rhythm that is regular but very fast. This condition causes the heart to beat too fast to pump blood effectively.
• Ventricular fibrillation (VF) is a ventricular tachyarrhythmia that has become unstable and irregular. VF causes the heart muscles to quiver in place, without a detectable rhythm.
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During ventricular fibrillation the body is quickly starved of oxygen, and the person usually passes out within a few seconds. VF is always life-threatening.
Here are some symptoms of tachyarrhythmia:
• Shortness of breath
• Dizziness
• Sudden weakness
Here are some causes of tachyarrhythmias:
• Heart-related conditions such as high blood pressure (hypertension), poor blood supply to the heart muscle due to coronary artery disease, heart valve disease, heart failure, tumors, and infections.
• Other medical conditions such as thyroid disease, certain lung diseases, electrolyte imbalance, and alcohol or drug abuse.
• Fluttering or pounding in the chest
• Light-headedness
•Fainting

Bradycardia – When the heart beats too slowly

Bradycardia is a slow or irregular heart rhythm, usually less than 60 beats per minute. When the heart rate is this slow, not enough
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oxygen-rich blood is pumped to the body. With this extremely slow heart rate, the heart cannot pump enough blood to the body to support daily activities or mild exercise.
Bradycardia can be caused by the delayed release of electrical impulses from the SA node (the heart rate determining mechanism) or when the normal pathway for electrical impulses in the heart is interrupted (heart block).
Here are some symptoms of bradycardia:
• Dizziness
• Shortness of breath
Here are some causes of bradycardia:
• Hereditary defects
• Certain illnesses
• Some cardiac drugs
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•Extreme fatigue
• Fainting spells
•The aging process
• A heart attack
• An unknown cause
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Figure 4: A normal heart rate compared to a bradycardia rate
Normal heart rate
72 beats per minute (bpm)
Bradycardia heart rate
45 beats per minute (bpm)
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About your heart device

4
Your doctor has prescribed a Medtronic implantable cardioverter defibrillator (ICD) to treat your heart disease symptoms. Although this heart device does not prevent or cure your underlying heart rhythm condition, it may improve the quality of your life.
This chapter should answer many of your questions about your heart device, including the following questions:
•What is an ICD?
• What types of therapies does my heart device provide?
• What does my heart device therapy feel like?
• Are there any special features I need to know about my heart device?
If you have questions that are not answered in this manual, contact Medtronic Patient Services (see page 3) or ask your doctor.
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What is an ICD?

Your ICD is part of complete treatment system that includes the following components:
•A heart device
• One or more leads
•A Medtronic CareLink Programmer used by your doctor to monitor and adjust the settings of your heart device

Your heart device

Your heart device contains a very small computer that is powered by a tiny lithium battery. All electronic components of your heart device are sealed inside a metal case made of titanium. Your device is designed to monitor your heart rate and deliver immediate treatment for any irregular heart rhythms when necessary.
The ICD provides two types of treatment or therapy for your heart, bradycardia pacing and defibrillation. For details about these therapies, see “What types of therapies does my heart device provide?” on page 70.
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Leads

A lead is a soft, insulated wire that relays electrical signals from your heart to your device to monitor your heart; a lead also delivers therapies to your heart when necessary. When your heart device is implanted, your doctor threads one end of the lead through a vein into your heart, then connects the other end of the lead to your heart device.
Figure 5: Example of a lead
With an ICD, a lead is placed inside the right ventricle. Another lead may be placed inside the right atrium (see Figure 6 on page 69). Your doctor will determine the best way to deliver the type of therapy needed to help relieve your heart disease symptoms.
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Your heart device constantly monitors your heart rate using the implanted leads. If your heart device detects an irregular heart rhythm, it provides therapy to the heart by releasing an electrical pulse or multiple pulses from the tip of the lead to the heart. For descriptions of the available types of therapies, see “What types of therapies does my heart device provide?” on page 70.
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Figure 6: The leads are attached to your heart device. Leads relay electrical signals from your heart to your device to monitor your heart and deliver therapies to your heart when needed.
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What does my heart device do?

Your heart device constantly monitors your heart rhythm. If your heartbeat is too slow, too fast, or uneven, your heart device delivers pulses of electricity from the tip of the implanted lead directly to your heart. This therapy is designed to help your heart beat in a regular rhythm. There are a few different types of therapies that your heart device can deliver. The therapy provided depends on the type of abnormal heart rhythm detected by your heart device.

What types of therapies does my heart device provide?

Your heart device can provide several types of therapies. Because your heart device is constantly monitoring the rhythm of your heart, it can detect irregular rhythms and automatically deliver the most appropriate type of therapy when it is needed.
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Therapies for a fast or uneven heart rhythm

Your heart device provides several therapies to treat a fast or uneven heart rhythm. Your doctor has set up your heart device to deliver the most effective type of therapy for your specific heart rhythm condition.
There are three kinds of therapies used to treat fast or uneven heart rhythms:
• Antitachycardia pacing (ATP)
• Cardioversion
• Defibrillation
Antitachycardia pacing (ATP) therapy
Antitachycardia pacing (ATP) is often the first type of therapy used by your heart device to treat a fast or uneven heart rhythm.
During antitachycardia pacing therapy, your heart device releases several short bursts of pacing pulses; then it pauses to check for a normal heart beat. If the heart rhythm is still irregular, the ATP therapy is repeated.
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If a normal rhythm is restored, no further treatment is delivered. If your heart rate is still too fast or uneven, your heart device delivers either cardioversion or defibrillation therapy to restore a normal heart rate.
Cardioversion therapy
Cardioversion therapy is used to treat an extremely fast but stable heart rhythm. Cardioversion therapy involves delivering a low-level shock to the heart at the same time as your natural heart beat. This therapy may increase to higher energy levels if the initial treatment is not successful.
Cardioversion therapy is typically used if an abnormally fast heart rhythm does not respond to ATP therapy.
Defibrillation therapy
If your heart device detects a very fast and unstable heart rhythm, it delivers a therapy shock to your heart. The clinical term for this therapy is defibrillation. This therapy is similar to the treatment provided by an external defibrillator, which uses paddles placed on the outside of the body over the heart. However, a much lower level of electricity is delivered by the heart device because this therapy is applied directly to the heart.
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Your heart device responds automatically with life-saving defibrillation during the first crucial seconds of a tachyarrhythmia (fast heart rhythms) when an emergency team may be minutes away or not available.
The therapy shock usually stops the abnormal electrical impulses that are causing your heart to beat too fast. After each therapeutic shock, your heart device monitors your heart for a normal rhythm and delivers another therapy shock if the rhythm is still too fast.
When a normal heart rhythm is restored, no further therapy is delivered.
For information on what to do if you receive a therapy shock, see “What if I receive a therapy shock?” on page 22.

Therapy for a slow heart rhythm

Bradycardia is a heart condition where the heart beats too slowly to provide enough blood for the body’s needs. Your heart device provides pacing therapy to treat a slow heart rhythm.
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Pacing therapy
If your heart’s rhythm becomes too slow, your heart device delivers a steady pattern of small electrical pulses to your heart to encourage a regular heartbeat. This is called pacing your heart. Pacing therapy was one of the very first treatments available from an implanted heart device commonly known as a pacemaker. The pacing therapy provided by your heart device ensures that your heart maintains a heart rhythm that supports your body’s needs.

What do the therapies feel like?

The experience of receiving heart device therapies varies from person to person. The sensations people have reported feeling during the different therapies are described next.
Antitachycardia pacing (ATP) – This therapy is often not felt at all and lasts only a short period of time. It may cause a rapid heart beat sensation, but the feeling is generally not reported as uncomfortable.
Cardioversion – This therapy is often described as “a thump on the chest” and can cause mild discomfort.
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Defibrillation – Some people lose consciousness as a result of their rapid heart beat and are not aware of receiving defibrillation (or therapy shock). Others who are awake during a therapy shock describe it as a “kick in the chest.” They say it startles them and that the feeling passes very quickly. Some people find the therapy shock a reassuring reminder that their heart device is protecting them from a sudden cardiac arrest, while others find it fleeting but also distressing.
Pacing therapy – Most people do not feel pacing therapies when they are delivered. The few that report feeling this type of therapy describe it as painless.

What is Medtronic CareAlert monitoring?

Your heart device has the ability to monitor itself and your lead system for proper functioning. This ability is provided through the Medtronic CareAlert monitoring feature. With the Medtronic CareAlert monitoring feature, your doctor can program your heart device to monitor itself for proper functioning and to monitor your heart for changes in your heart rhythm. Your heart device may alert you to contact your doctor by emitting a beeping sound. If you hear a beeping sound, contact your
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doctor. Your doctor can discuss what has occurred and can further evaluate changes pertaining to the device or particular rhythms.
If you have a Medtronic CareLink Monitor, your doctor can also program your heart device to automatically send heart information through the monitor to your clinic without having your heart device beep.
Using the Medtronic CareAlert monitoring feature, your doctor chooses to monitor device function, your heart rhythm, or both. Ask your doctor if this feature is turned on and which conditions are being monitored. You should discuss whether there is likely to be a beeping sound. This will help you understand the purpose of Medtronic CareAlert monitoring and how your doctor has programmed the device to meet your needs. But remember, if your device makes a sound, you should always contact your doctor unless otherwise directed.

Conditions that Medtronic CareAlert monitoring can detect

At the time your heart device is implanted or during a routine follow-up appointment, your doctor can set Medtronic CareAlert monitoring to alert you about things such as the following:
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• Heart device battery status
• The status of your leads
• The number of therapies detected
Additionally, your heart device can monitor for changes in your heart rhythm that your doctor may want to be aware of. If one of these conditions is detected by your heart device, it will make a beeping sound for up to 30 seconds, at least once a day. Call your doctor if your heart device starts to make a beeping sound.

Checking your Medtronic CareAlert status

Your doctor may give you a Patient Magnet to check your Medtronic CareAlert status. To check if the Medtronic CareAlert monitoring feature has triggered an alert, place your Patient Magnet over your heart device.
• If an alert has occurred, your heart device will make a beeping tone (on/off or high/low pitch) when a Patient Magnet is placed over your device.
• If no alert has occurred, your heart device will make a steady tone (hummm) when a Patient Magnet is placed over your device.
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Cautions:
Never carry, store, or leave the Patient Magnet over your heart device. Your heart device cannot treat a tachyarrhythmia (fast heart rhythm) while the magnet is placed over it.
The Patient Magnet is a special magnet and should be used only as directed by your doctor. Other magnets should never be placed over or held close to your heart device (see “General guidelines for avoiding interference from electrical items or magnets” on page 32 for more information).
Your nurse or doctor will explain how to use the Patient Magnet and what to do if an alert has occurred; you can also refer to the Patient Magnet manual for additional information.
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Your implant procedure and
5
Being told you need a heart device can be upsetting, but knowing what to expect about your implant procedure can help reduce your concern. The implant procedure does not require open heart surgery. You will be given medication to make you sleepy and comfortable, but the surgery is typically performed using local anesthesia.
You will usually stay in the hospital overnight and go home the next day with instructions on caring for your incision. For a short time after surgery, your doctor may want you to limit how much you move the arm that is closest to your implant site.
This chapter has important information about the following topics:
• The implant procedure
• Potential risks after the implant procedure
• Recovering after your surgery and keeping follow-up appointments
recovery
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The implant procedure

The implant procedure includes these general steps:
1. Making the incision and inserting the leads.
2. Testing the leads.
3. Implanting the heart device and closing the incision.

Making the incision and inserting the leads

Your doctor will make a small incision, just below your collarbone, on the left or right side of your chest. (Sometimes heart devices are implanted in the abdominal area in children or small adults.)
The doctor inserts the two leads into a vein, threading each through the vein into your heart. The tip of each lead is positioned so that it touches the inside wall of your heart. This type of lead is called a transvenous lead.
Sometimes a lead needs to be placed on the outside of the heart. This type of lead is called an epicardial lead or patch lead. If this type of lead is needed, your doctor inserts it by making a small incision between your ribs just over your heart.
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In general, leads are referred to by their location in your heart:
• An atrial lead is placed in the right atria.
• A right ventricular lead is placed inside the right ventricle.

Testing the leads

After each lead is placed in your heart, it is tested to make sure that it will operate effectively. Your doctor tests each lead to make sure that it can accurately monitor your heart rate and deliver heart rhythm therapies.

Implanting the heart device and closing the incision

After testing, the leads are attached to your heart device. The heart device is then implanted under the skin. Your doctor tests the heart device and implanted leads to confirm that they are operating effectively, then closes the incision.
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Potential risks after the implant procedure

Your doctor and Medtronic have attempted to minimize the risks associated with implanting a heart device. However, as with any kind of surgery, there are potential risks.
The following potential risks are associated with implanting a heart device:
• Pain, swelling, or bruising around the implant site
• Bleeding
•Infection
• Blood clots
• Punctures of the heart muscle, vein, or lung space caused while implanting the leads
• Heart attack
•Stroke
Your doctor should discuss these and other potential risks of this surgical procedure with you.
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After the implant procedure is finished, there is a potential risk of additional hospitalization or surgery to modify or adjust your implanted heart device. Additional hospitalization may be required under some conditions, such as these:
• Movement of the heart device from its original location or wearing away of the skin over the heart device
• Changes in your heart rhythms that require adjustment or changes to the lead system
• Changes in the lead system that prevent the heart device from detecting the heart rhythm or delivering therapies
• Stimulation of muscles other than the heart muscle by the heart device

Recovering after your implant surgery

Some time after your heart device is implanted, your doctor may order some tests such as an ECG, blood tests, or x-rays to confirm that your leads are in the proper position inside your heart. The operating settings for your heart device may also be checked again to make sure that your heart device is providing the best treatment for your heart condition.
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As you recover, follow your doctor’s suggestions about resuming normal activities. Expect a gradual recovery. It is normal to see a slight bulge under your skin where the heart device is located.
Here are general recommendations for the first few weeks after your surgery:
• Call your doctor immediately if any swelling, warmth, or drainage appears around your incision or if you develop a fever.
• Use care when exercising and bathing, according to your doctor's directions.
• Avoid tight clothing that may irritate your incision.
• Limit arm movements as directed by your doctor.
• Avoid lifting more than 10 to 15 pounds (5 to 7 kilograms).
• Avoid excessive twisting of your torso.
• Avoid pushing or pulling heavy objects.
• When you are driving or riding in a vehicle, the shoulder seat belt strap may feel uncomfortable. You can place a soft towel between the shoulder seat belt strap and your implant site to cushion the area
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during the first few weeks after surgery. In any case, seat belts should be worn at all times.
Tell your other doctors and your dentist that you have a heart device. They may choose to prescribe antibiotics for you to take before and after surgery or dental work to prevent infection.

Follow-up appointments

Your doctor or nurse will work with you to schedule follow-up care appointments. For more information about these appointments, read Chapter 7, “Follow-up care” on page 93.
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Registering your heart device

6
Registering your heart device is important. Registration ensures that medical information related to your heart device is on file and that Medtronic can notify your doctor with any relevant device information if necessary.
The Food and Drug Administration (FDA) requires that medical device companies keep track of their devices implanted in the United States. The registration information must be accurate and current. This information is always kept confidential.
This chapter has important information about the following topics:
• Heart device registration form
• Heart device identification (ID) card
• Heart device travel card
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Heart device registration form

In the United States and its territories, the heart device registration form is completed by your doctor, nurse, or Medtronic representative at the time of your implant. This form is then sent to Medtronic.
The form includes this information:
• Your name and contact information
• Heart device model and serial number
• Date of implant
• Your follow-up care doctor’s name and phone number
This same information is included on your temporary and permanent heart device ID card.
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Your heart device ID card

While in the hospital, you will receive a temporary heart device ID card. Your permanent card will be mailed to you within 6 weeks of your implant. If you have not received your card within 6 weeks of your implant surgery, contact Medtronic Patient Registration Services at 1-800-551-5544. Our staff is available Monday through Friday, 7:00 AM to 6:00 PM (Central Standard Time).

Carry your heart device ID card with you at all times

Your heart device ID card is especially helpful during your follow-up appointments, when seeing other doctors or your dentist, and when traveling. It could be essential in case of a medical emergency. You should carry your heart device ID card with you at all times.
If you do not have your heart device ID card with you during a medical situation, your doctor or nurse can call Medtronic (or the medical records department of the hospital where your heart device was implanted) to request information about your heart device.
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To request a new heart device ID card or update your personal information

If you lose your heart device ID card or need to update your personal information, such as your address or name, contact Medtronic Patient Registration Services at 1-800-551-5544 or update your information online at www.medtronic.com/idcard. Also, notify Medtronic if you no longer reside in the United States.

If you change your doctor

If you change your heart doctor or if the contact information for your doctor changes, notify Medtronic Patient Registration Services by calling 1-800-551-5544 or by updating your ID card information online at www.medtronic.com/idcard.

Medtronic heart device travel card

A special Medtronic heart device travel card is also available from Medtronic. This multilanguage card identifies you as having an implanted heart device and provides instructions for security personnel on how to properly scan your heart device with a handheld scanner.
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You can use this card, along with your heart device ID card, when you pass through security gates at airports and other secured buildings such as some libraries and government buildings. The travel card is especially useful when traveling internationally.
You can request the Medtronic heart device travel card by calling Medtronic Patient Registration Services at 1-800-551-5544 or at www.medtronic.com/rhythms.
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Follow-up care

7
Before you leave the hospital, your doctor will tell you when you need to schedule a follow-up appointment.
Follow-up appointments are important to ensure that your heart device settings are working well for you. No surgery is required, and the procedure is painless. The appointment usually takes the same amount of time as a regular doctor’s appointment.
In the past, follow-up appointments had to be done at a clinic or in your doctor’s office. Today, you and your doctor have more options. Most Medtronic heart devices are supported by the Medtronic CareLink Service. This service allows you to provide your heart device follow-up information to your doctor from your own home, from work, or even while traveling.
For more information about the Medtronic CareLink Service, see “Remote monitoring with the Medtronic CareLink Service” on page 95.
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Follow-up information

The purpose of follow-up appointments is to check or monitor the following types of information:
• Assess your general medical condition.
• Check the operation of your heart device. This includes checking the battery power and the status of your implanted leads.
• Review the information saved by your heart device.
• Adjust your heart device settings, if necessary, to provide the best treatment for your heart condition.
Your doctor or nurse will review your current medications with you and can answer any questions you have during the visit.
Your doctor will tell you how often your heart device should be checked. Your first follow-up appointment is usually scheduled for 1 month after your heart device is implanted.
Depending on your doctor’s normal practice and your medical condition, additional follow-up appointments are scheduled every 3 to 6 months. More frequent appointments are usually scheduled as your heart device nears its expected replacement time.
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Remote monitoring with the Medtronic CareLink Service

Your clinic may offer the Medtronic CareLink Service for your heart device. The Medtronic CareLink Service allows you to send your heart device information to your clinic instead of visiting in person, so you will not have to leave your home for most follow-up appointments. The information you send is available for your clinic’s review within minutes. If the heart device information that is automatically sent to your doctor indicates that you should be seen in person, your doctor or clinic will contact you to set up an appointment. The doctor may need to adjust your heart device settings or adjust your medications.
The Medtronic CareLink Service allows you to send your heart device information from wherever you have access to a standard phone line within the United States. When you do not have access to a standard phone line or when you are traveling outside the United States, contact Medtronic Patient Services (see page 3) or your device clinic to discuss your options. One option may be to use the service with a Medtronic cellular accessory.
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Medtronic CareLink Service
The Medtronic CareLink Monitor transmits your heart device information over a standard phone line or through a cellular accessory. No internet connection is needed.
Your clinic can review your data on the clinician website within minutes.
Most patients feel that the Medtronic CareLink Service is convenient and provides peace of mind. If your doctor prescribes this service, your clinic will provide you with a Medtronic CareLink Monitor. The monitor comes with complete instructions and is simple for you, your family, or your care provider to use. You typically place the monitor on a table next to your bed so that while you are in bed, the monitor can communicate wirelessly with your Medtronic heart device. The monitor automatically
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sends follow-up information through the CareLink Network to your heart clinic at a time set up by you and your doctor (for example, during sleeping hours). The monitor is easy to take with you if you plan to travel within the United States. It weighs about 1 pound (0.5 kilograms) and fits inside a suitcase or carry-on baggage.
Will the Medtronic CareLink Service replace all clinic visits?
The Medtronic CareLink Service and Medtronic CareLink Monitor are not meant to replace all clinic visits. If you feel that you need to see your doctor, do not hesitate to contact your clinic. Sometimes, in order to determine the best course of action for you, your doctor may ask you to transmit your heart device information before coming to the clinic.
Can I use the Medtronic CareLink Monitor to contact my doctor in an emergency?
No. In any emergency situation, always call 911. Unless instructed by your doctor, do not use the Medtronic CareLink Monitor to send heart device information during an emergency.
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Is there any additional cost for the Medtronic CareLink Service?
Remote monitoring with the Medtronic CareLink Service is provided in the United States as a standard feature with most Medtronic heart devices. Your cost for using the Medtronic CareLink Service will be the same as a normal clinic visit co-payment. The service is also available in more than 30 countries. For more information about the Medtronic CareLink Service and Medtronic CareLink Monitor, talk with your doctor. You can also find information on the Medtronic website at www.medtronic.com.

Medtronic CareLink Programmer

The Medtronic CareLink Programmer is a specialized computer designed to work specifically with your Medtronic heart device.
Your doctor or nurse uses the programmer during the implant procedure to initially set up and change the heart device settings. Using radio waves to “read” your heart device, the programmer displays information that is collected and stored in your heart device.
Your doctor or nurse uses the Medtronic CareLink Programmer during every follow-up appointment to make sure that your heart device is
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operating correctly and to check for any changes in your heart rhythm condition.

Reviewing information saved by your heart device

During a follow-up appointment in the clinic or hospital, your doctor or nurse will use the Medtronic CareLink Programmer to read data collected by your heart device or to change the operating settings of your heart device. Your heart device collects and saves the following information:
• ECG recordings of any unusual heart rhythms
• A list of any therapies you have received
• The status of the heart device battery
• The status of your implanted leads
Based on this information and a review of your medications, your doctor may adjust the settings of your heart device to fit your individual needs.
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When to call your doctor or nurse

Contact your doctor or nurse if you experience any of the following situations:
• You notice any swelling, warmth, or drainage around your incision or if you develop a fever while your incision is healing.
• You notice new, unexplained heart symptoms or if you experience the same heart symptoms you had before receiving your heart device.
• You have heart rhythm symptoms that last longer than 3 minutes (or any length of time specified by your doctor). These symptoms can include extreme fatigue, racing heart, pounding heart, or feeling faint or dizzy.
• You hear beeping tones coming from your heart device. For more information on the Medtronic CareAlert monitoring feature, see “What is Medtronic CareAlert monitoring?” on page 75.
• You receive a shock from your heart device and your doctor has instructed you to call. For more information, see “What if I receive a therapy shock?” on page 22.
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